In vitro data still has an important place in EFSA dossiers, says expert
The industry wide challenge to obtain EFSA approved health claims for ingredients and their related health effects continues to confuse many when it comes to the data that may be required.
Indeed, the latest insight and guidance from the scientific body places great emphasis on in vivo data from human trials. However, this sort of data is not enough alone, says Czank.
"What we have to remember is that EFSA is going to look at the totality of the evidence," explained the Leatherhead expert."What we mean by that is that it's not just the human studies that are important - what we need the human studies to do is build on a base of in vitro data."
"That in vitro data can support things looking at the mechanisms and also characterising the food constituent itself."
Czank added that mechanistic and bioavailability studies performed in vitro are still of significant importance for industry, and warned that failure to include such data in an EFSA submission will mean a greater chance of negative opinions.
